Bio-mechanically compatible 3D-printed intervertebral disk

ABSTRACT

An artificial replacement disk configured to be positioned in between a superior vertebrae and an inferior vertebrae. The upper and lower surfaces match the surface morphologies of the corresponding vertebrae and may be textured to promote bone in-growth. The artificial replacement disk may comprise gripping structures to permit easy manipulation of the artificial replacement disk during surgical procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and is a Continuation of U.S.Non-provisional application Ser. No. 17/712,065, filed on Apr. 1, 2022,which is a Continuation-in-part of U.S. Non-provisional application Ser.No. 17/035,582, filed on Sep. 28, 2020, which claims the benefit of U.S.provisional patent application No. 62/906,858, filed on Sep. 27, 2019,the contents of which are incorporated by reference in their entirety.

FIELD OF THE INVENTION

This invention relates generally to artificial disk replacement andfusion devices, and more specifically to bio-mechanically compatible 3D-printed implant devices for human and animal spines.

BACKGROUND OF THE INVENTION

There are several artificial disk replacement and fusion devicesavailable on the market today for spinal correction procedures,replacing damaged cushioning tissue—called vertebral disk—locatedbetween the vertebrae, as illustrated in FIG. 1A. The replacement mustbe safe to implant, reliable and long lasting.

With an artificial disk replacement procedure, the implant mustreplicate the movement of a natural disk. With a fusion procedure, theimplant must lock the vertebrae in place permanently. Some examplesinclude the Bryan cervical artificial disk and the Charite lumbarartificial disk by Medtronic, the M6 disk by Spinal Kinetics, and theESP disk by FH Orthopedics.

Typically, the disk replacement procedure is performed under generalanesthesia with the help of X-ray imaging technology. While holding thedisk space between the two vertebrae open, the disk is removed using amicroscope and surgical instruments specifically made for this purpose.Once the disk has been safely removed, the space is increased to restorethe natural height and to allow the implant to be inserted. Theendplates (top and bottom of each vertebrae) are then prepared toincorporate the artificial disk or fusion device. When the artificialdisk or fusion device is firmly in place, the tension is taken off thevertebral bodies above and below, thereby recompressing the artificialdisk or fusion device and thus holding it in place, as illustrated inFIG. 1B for an artificial disk device or in FIG. 1C for a fusion device.

Typically, the implants are made of metal such as titanium, to promoteingrowth of bony material for long-term stability. However, thisprocedure carries some risks associated with milling and shaping of theendplates, which could result in potential damage of nearby disks,nerves, blood vessels, joints and the vertebral bodies. Moreover, themismatch between the surface morphology of the implant and that of thebone endplates could potentially cause a poor connection potentiallyresulting in loosening of the prosthesis, potential subsidence, as wellas non-uniform ingrowth of bony material, hence affecting the long-termstability of the implant. The embodiments and methods of the presentinvention solve the above-mentioned problems associated with theartificial disk replacement and fusion devices and procedures byincorporating a 3D printed implant device, which matches the matingsurface of the implant and the surface morphology of the bone endplates,thereby eliminating the need of milling and shaping, preventingloosening of the disk, increasing its immediate post-operative andlong-term stability.

SUMMARY OF THE EMBODIMENTS

In one aspect, an interface device includes a first surface that matchesthe surface morphology of the corresponding artificial disk and a secondsurface that matches the surface morphology of the correspondingendplate of the vertebrae. The interface device of the presentdisclosure can be fabricated using three-dimensional additivemanufacturing printing technology.

A method for fabricating an interface device includes acquiringthree-dimensional image scan data of spine or neck using computerizedtomography (CT) scan or magnetic resonance imaging (MM) or both,converting the CT and/or MM scan to an engineering file, creating athree-dimensional digital model of a vertebrae's endplate, obtaining athree-dimensional digital model of a corresponding mating surface of theartificial replacement disk, combining the three-dimensional digitalmodel of the vertebrae's endplate and three-dimensional digital model ofthe mating surfaces of the artificial replacement disk, outputting thecombined three-dimensional digital model, and printing the interfacedevice.

According to the present disclosure, a method for directly printing aninterface device on the surface of an artificial disk includes acquiring3D image scan data of spine or neck using Computerized Tomography (CT)scan and/or Magnetic Resonance Imaging (MRI) scan, converting the CTand/or MRI scan to an engineering file, creating a 3D digital model ofthe vertebrae's endplate, obtaining a 3D digital model of thecorresponding matting surfaces of the artificial replacement disk,combining the 3D digital model of the vertebrae's endplate and the 3Ddigital model of the matting surfaces of the artificial replacementdisk, outputting the combined 3D digital model, positioning theartificial replacement disk on a printing tray of a 3D printer, andprinting the interface device on the surface of the artificialreplacement disk.

Further according to the present disclosure, a method for fabricating anartificial replacement disk comprises the steps of acquiringthree-dimensional image scan data of spine or neck using at least one ofcomputerized tomography (CT) scan and magnetic resonance imaging (MRI),converting the CT and/or Mill scan to an engineering file, creating athree-dimensional digital model of a target disk space in between asuperior vertebrae and an inferior vertebrae, printing a first endplateand a second endplate, and injection molding a core in between the firstinner surface and the second inner surface to create the artificialreplacement disk assembly.

Further according to the present disclosure, a method of fabricating anartificial replacement disk comprises the steps of acquiringthree-dimensional image scan data of spine or neck using at least one ofcomputerized tomography (CT) scan and magnetic resonance imaging (MRI),converting the CT and/or Mill scan to an engineering file, creating athree-dimensional digital model of a target disk space in between asuperior vertebrae and an inferior vertebrae, printing a first endplateand a second endplate, molding a core, fusing the core to the endplatesto create the artificial replacement disk assembly.

Other aspects, embodiments and features of the device and method of thepresent invention will become apparent from the following detaileddescription when considered in conjunction with the accompanyingfigures. The accompanying figures are for schematic purposes and are notintended to be drawn to scale. In the figures, each identical orsubstantially similar component that is illustrated in various figuresis represented by a single numeral or notation. For purposes of clarity,not every component is labeled in every figure. Nor is every componentof each embodiment of the device and method shown where illustration isnot necessary to allow those of ordinary skill in the art to understandthe device and method.

BRIEF DESCRIPTION OF THE DRAWINGS

The preceding summary, as well as the following detailed description ofthe disclosed device and method, will be better understood when read inconjunction with the attached drawings. It should be understood,however, that neither the device nor the method is limited to theprecise arrangements and instrumentalities shown.

FIGS. 1A-1C illustrate a conventional method of vertebral diskreplacement.

FIGS. 2A and 2B are schematic illustration of the artificial diskinterface device in accordance with the embodiments of the presentdisclosure.

FIG. 3 is a block diagram depicting an example of a computing device asdescribed herein.

FIG. 4 is a schematic flowchart illustrating the steps of a method formanufacturing an artificial disk interface device in accordance with theembodiments of the present invention.

FIG. 5 is a schematic flowchart illustrating the steps of a method formanufacturing an artificial disk interface device in accordance withanother embodiment of the present invention.

FIGS. 6A, 6B, and 6C illustrate a conventional process of producingspinal implants.

FIG. 7 is an illustration of a 3D -printed artificial endplates.

FIG. 8 illustrates the lattice structures using 3-D printing methods.

FIG. 9 shows varying angles between the vertebrae bone endplates.

FIGS. 10A-10B is a schematic illustration of the disk in accordance withthe embodiments of the present disclosure.

FIG. 11A is a schematic illustration of the disk in accordance with theembodiments of the present disclosure with the core comprised ofmaterials having different stiffness.

FIG. 11B shows a vertical displacement of the facet joints in a standarddisk versus minimal vertical displacement of the facets in a disk havingthe tougher core closer to the spinal cord in accordance with anembodiment of the present invention.

FIG. 12 illustrates the flaws or imperfections of the prior artartificial disks.

FIG. 13 is an illustration of an oversized prior art implant.

FIGS. 14A and 14B illustrates some alternative embodiments of thepresent disclosure.

FIG. 15 shows another embodiment of the present disclosure.

FIG. 16 is a schematic diagram illustrating the support structures ofthe ligaments that restrict rotation of the L4 and L5 vertebrae.

FIG. 17 shows the implant with protrusions in accordance with anotherembodiment of the present disclosure.

FIG. 18 is a schematic illustration of the disk in accordance with theembodiments of the present disclosure showing endplates with slots forgripping.

FIGS. 19-20 shows a portion of the endplate having a plurality of slotsfor gripping.

FIGS. 21A-21C show a multi-prong gripping configuration.

FIGS. 22A-22C show another multi-prong gripping configuration.

FIG. 23 is a schematic flowchart illustrating the steps of a method formanufacturing an artificial replacement disk assembly in accordance withthe embodiments of the present invention.

FIGS. 24A-24G depict the steps of method of FIG. 23 , in accordance withone embodiment of the present invention.

FIG. 25 is a schematic flowchart illustrating the steps of a method formanufacturing an artificial replacement disk assembly in accordance withthe embodiments of the present invention.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

As shown in FIG. 2A, the interface device 220 of the present disclosure,positioned between artificial replacement disk 210 and vertebrae 230, isdesigned to match surface morphology of the corresponding matingsurfaces of the replacement disk and the vertebrae. Hence, the topsurface 222 of the interface device 220 conforms to the correspondingbottom surface 214 of the replacement disk 210 for mating the interfacedevice with the artificial disk. Likewise, the bottom surface 224 of theinterface device 220 conforms to the corresponding top surface(endplate) 232 of the vertebrae 230 for mating the interface device withthe vertebrae.

In some other instances, when, for example, the artificial disk 210includes tabs 216, as illustrated in FIG. 2B, the interface device isdesigned to include grooves 226 disposed to fit into corresponding tabs216. It will be appreciated by a person skilled in the art that the topsurface of the interface device can be designed to conform to anysurface morphology of the corresponding surface of the artificial disk.If the disk includes grooves, then the interface device can includecorresponding tabs for mating the disk with the interface device, etc.

In some instances, the artificial disk can be sandwiched between twointerface devices, i.e., a second interface device can be disposed ontop of the artificial disk, for mating with the top surface 212 of theartificial disk 210, wherein the top surface of the second interfacedevice conforms to the surface morphology of the endplate of a secondvertebrae (not shown).

In some embodiments, the interface device of the present invention canmatch the shape of the artificial disk, for example if the disk is oval,then the interface device is designed to be oval as well, or if the diskis circular, the interface device can be circular in shape, and so on.The interface device can be made of porous metal such as titanium, orPEEK material (Polyetheretherketone), which is a semi-crystallineorganic thermoplastic polymer, or any other suitable biocompatiblematerials. In some preferred embodiments, the porosity of the materialof the interface device can substantially match that of the artificialdisk. In some other instances, the porosities of the interface deviceand the disk can be different. In some preferred instances the interfacedevice and the artificial disk are made of the same material such asporous titanium, for example. In some embodiments, the materials can bedifferent, e.g., the disk is made of titanium and the interface deviceis made of PEEK polymer. The interface device can also be treated with abiocompatible material such as hydroxyapatite (HA) for improved bonegrowth to the implant devices.

The interface device of the present invention can be fabricated usingthree-dimensional (“3D ”) printing technology, producing it directlyfrom digital descriptions that include output of any software capable ofgenerating a 3D digital model. One example of such software isComputer-Aided Design (CAD) software, which can be implemented on one ormore computing devices. Some embodiments of the disclosed device andmethod will be better understood by reference to the following commentsconcerning these computing devices.

A “computing device” 100 may be defined as including personal computers,laptops, tablets, smart phones, and any other computing device capableof supporting an application as described herein. The system and methoddisclosed herein will be better understood in light of the followingobservations concerning the computing devices that support the disclosedapplication, and concerning the nature of web applications in general.An exemplary computing device is illustrated by FIG. 3 . The processor101 may be a special purpose or a general-purpose processor device. Aswill be appreciated by persons skilled in the relevant art, theprocessor device 101 may also be a single processor in amulti-core/multiprocessor system, such system operating alone, or in acluster of computing devices operating in a cluster or server farm. Theprocessor 101 is connected to a communication infrastructure 102, forexample, a bus, message queue, network, or multi-core message-passingscheme.

The computing device also includes a main memory 103, such as randomaccess memory (RAM), and may also include a secondary memory 104.Secondary memory 104 may include, for example, a hard disk drive 105, aremovable storage drive or interface 106, connected to a removablestorage unit 107, or other similar means. As will be appreciated bypersons skilled in the relevant art, a removable storage unit 107includes a computer usable storage medium having stored therein computersoftware and/or data. Examples of additional means creating secondarymemory 104 may include a program cartridge and cartridge interface (suchas that found in video game devices), a removable memory chip (such asan EPROM, or PROM) and associated socket, and other removable storageunits 107 and interfaces 106 which allow software and data to betransferred from the removable storage unit 107 to the computer system.In some embodiments, to “maintain” data in the memory of a computingdevice means to store that data in that memory in a form convenient forretrieval as required by the algorithm at issue, and to retrieve,update, or delete the data as needed.

The computing device may also include a communications interface 108.The communications interface 108 allows software and data to betransferred between the computing device and external devices. Thecommunications interface 108 may include a modem, a network interface(such as an Ethernet card), a communications port, a PCMCIA slot andcard, or other means to couple the computing device to external devices.Software and data transferred via the communications interface 108 maybe in the form of signals, which may be electronic, electromagnetic,optical, or other signals capable of being received by thecommunications interface 108. These signals may be provided to thecommunications interface 108 via wire or cable, fiber optics, a phoneline, a cellular phone link, and radio frequency link or othercommunications channels. Other devices may be coupled to the computingdevice 100 via the communications interface 108. In some embodiments, adevice or component is “coupled” to a computing device 100 if it is sorelated to that device that the product or means and the device may beoperated together as one machine. In particular, a piece of electronicequipment is coupled to a computing device if it is incorporated in thecomputing device (e.g. a built-in camera on a smart phone), attached tothe device by wires capable of propagating signals between the equipmentand the device (e.g. a mouse connected to a personal computer by meansof a wire plugged into one of the computer's ports), tethered to thedevice by wireless technology that replaces the ability of wires topropagate signals (e.g. a wireless BLUETOOTH® headset for a mobilephone), or related to the computing device by shared membership in somenetwork consisting of wireless and wired connections between multiplemachines (e.g. a printer in an office that prints documents to computersbelonging to that office, no matter where they are, so long as they andthe printer can connect to the internet). A computing device 100 may becoupled to a second computing device (not shown); for instance, a servermay be coupled to a client device, as described below in greater detail.

The communications interface in the system embodiments discussed hereinfacilitates the coupling of the computing device with data entry devices109, the device's display 110, and network connections, whether wired orwireless 111. In some embodiments, “data entry devices” 109 are anyequipment coupled to a computing device that may be used to enter datainto that device. This definition includes, without limitation,keyboards, computer mice, touchscreens, digital cameras, digital videocameras, wireless antennas, Global Positioning System devices, audioinput and output devices, gyroscopic orientation sensors, proximitysensors, compasses, scanners, specialized reading devices such asfingerprint or retinal scanners, and any hardware device capable ofsensing electromagnetic radiation, electromagnetic fields, gravitationalforce, electromagnetic force, temperature, vibration, or pressure. Acomputing device's “manual data entry devices” is the set of all dataentry devices coupled to the computing device that permit the user toenter data into the computing device using manual manipulation. Manualentry devices include without limitation keyboards, keypads,touchscreens, track-pads, computer mice, buttons, and other similarcomponents. A computing device may also possess a navigation facility.The computing device's “navigation facility” may be any facility coupledto the computing device that enables the device accurately to calculatethe device's location on the surface of the Earth. Navigation facilitiescan include a receiver configured to communicate with the GlobalPositioning System or with similar satellite networks, as well as anyother system that mobile phones or other devices use to ascertain theirlocation, for example by communicating with cell towers. In someembodiments, a computing device's “display” 109 is a device coupled tothe computing device, by means of which the computing device can displayimages. Display include without limitation monitors, screens, televisiondevices, and projectors.

Computer programs (also called computer control logic) are stored inmain memory 103 and/or secondary memory 104. Computer programs may alsobe received via the communications interface 108. Such computerprograms, when executed, enable the processor device 101 to implementthe system embodiments discussed below. Accordingly, such computerprograms represent controllers of the system. Where embodiments areimplemented using software, the software may be stored in a computerprogram product and loaded into the computing device using a removablestorage drive or interface 106, a hard disk drive 105, or acommunications interface 108.

Computer program code for carrying out operations of the presentinvention may be written in an object oriented programming language suchas, but not limited to, Java, Smalltalk or C++. However, the computerprogram code for carrying out operations of the present invention mayalso be written in conventional procedural programming languages such asthe “C” programming language. Computer readable program instructions forcarrying out operations of the present invention may also be assemblerinstructions, instruction-set-architecture (ISA) instructions, machineinstructions, machine dependent instructions, microcode, firmwareinstructions, state-setting data, or either source code or object codewritten in any combination of one or more programming languagesdescribed above. In some instances, the computer readable program can beexecuted in the reverse order, depending upon the functionalityinvolved. It will also be noted that each block of the flowchartillustrations, and combinations of blocks in the flowchartillustrations, can be implement by special purpose hardware-basedsystems that perform the specified functions or acts or carry outcombinations of special purpose hardware and computer instructions.

The computing device may also store data in database 112 accessible tothe device. A database 112 is any structured collection of data. As usedherein, databases can include “NoSQL” data stores, which store data in afew key-value structures such as arrays for rapid retrieval using aknown set of keys (e.g. array indices). Another possibility is arelational database, which can divide the data stored into fieldsrepresenting useful categories of data. As a result, a stored datarecord can be quickly retrieved using any known portion of the data thathas been stored in that record by searching within that known datum'scategory within the database 112, and can be accessed by more complexqueries, using languages such as Structured Query Language, whichretrieve data based on limiting values passed as parameters andrelationships between the data being retrieved. More specializedqueries, such as image matching queries, may also be used to search somedatabases. A database can be created in any digital memory.

Persons skilled in the relevant art will also be aware that while anycomputing device must necessarily include facilities to perform thefunctions of a processor 101, a communication infrastructure 102, atleast a main memory 103, and usually a communications interface 108, notall devices will necessarily house these facilities separately. Forinstance, in some forms of computing devices as defined above,processing 101 and memory 103 could be distributed through the samehardware device, as in a neural net, and thus the communicationsinfrastructure 102 could be a property of the configuration of thatparticular hardware device. Many devices do practice a physical divisionof tasks as set forth above, however, and practitioners skilled in theart will understand the conceptual separation of tasks as applicableeven where physical components are merged.

As illustrated in FIG. 4 , the method of fabricating the interfacedevice of the present disclosure includes acquiring 3D image scan dataof spine or neck using Computerized Tomography (CT) scan and/or MagneticResonance Imaging (MRI) (step 100), converting the CT and/or MRI scan toan engineering file (200), creating a 3D digital model of thevertebrae's endplate (300) using a commercially-available software suchas Solidworks CAD, for example, obtaining a 3D digital model of thecorresponding mating surface of the artificial replacement disk (400),combining the 3D digital model of the vertebrae's endplate and the 3Ddigital model of the mating surfaces of the artificial replacement disk(500), outputting the combined 3D digital model (600) and printing theinterface device (700) using the three-dimensional printing technology,such as 3D printer. According to some embodiments of the presentinvention, a 3D digital model of the surface morphology of thecommercially available replacement disks can be stored and retrievedfrom the database maintained locally or remotely on the server (such asdatabase 112 of FIG. 3 ).

It can be appreciated by a person skilled in the art that this processdescribed above can be also applied in the same manner for 3D printingof the artificial replacement disk as one integral part, such that thetop and/or bottom surfaces of the disk conform to the correspondingmating surfaces of the corresponding vertebrae's endplates, as discussedin more detail in reference to FIGS. 6-17 below.

In some instances, the interface device can be directly printed on thesurface of the artificial disk as illustrated by the method of FIG. 5 .The method includes acquiring 3D image scan data of spine or neck usingComputerized Tomography (CT) scan and/or Magnetic Resonance Imaging(Mill) scan (step 1000), converting the CT and/or MM scan to anengineering file (1100), creating a 3D digital model of the vertebrae'sendplate (1200), obtaining a 3D digital model of the correspondingmatting surfaces of the artificial replacement disk (1300), combiningthe 3D digital model of the vertebrae's endplate and the 3D digitalmodel of the matting surfaces of the artificial replacement disk (1400),outputting the combined 3D digital model (1500), positioning theartificial replacement disk on a printing tray of a 3D printer (1600),and printing the interface device on the surface of the artificialreplacement disk (1700).

In some embodiments of the present invention, a 3D printer can becombined with a 3D scanner for scanning the surface of the artificialreplacement disk prior to printing on its surface, thereby gainingaccurate data on that surface before the print begins and eliminating alaser line distortion when it hits the object on the 3D printer'sprinting bed. Alternatively, the disk and the interface device can betwo separate parts as described above with reference to FIGS. 2A-2B.

Once fabricated, the interface device can be disposed on top and/orbottom of the artificial disk and used in the artificial diskreplacement procedure described in the background section of the presentdisclosure. The interface device can be permanently attached to theartificial disk using any suitable attaching means such as glue, forexample; or it can be detachably attached by way of correspondingprotrusions and grooves, such as illustrated in FIG. 2B; or it can beplaced on the artificial disk without using any attaching means (i.e.,the interface device and artificial disk are being pressed together byforce of two vertebrae between which the device and disk arepositioned). In some instances, one interface device can be disposed ontop of the artificial disk and another interface device can be disposedon the bottom of the artificial disk. It can also be directly printed onthe surface of the artificial disk, as discussed above in related to amethod illustrated in FIG. 5 , forming one integrated part, or it can becomprised of two separate parts.

Below is a more detailed discussion of application of thebio-mechanically compatible 3D -printed intervertebral disk of thepresent disclosure for solving many problems in the human spine related,but not limited to, intervertebral disk diseases.

The practical application and combination of medical imaging, as shownin FIG. 6A, 3D analysis & software conversion to a 3D engineering file(FIG. 6B), surgery preparation software and 3D printing techniques (FIG.6C) to produce spinal implants (both fusion implants and functional,moveable artificial intervertebral disks) which are custom shaped perpatient, per level (any level of the human spine).

These are 3D printed artificial endplates made of any biocompatiblematerial to match the natural shape of the patient's bone structure, asillustrated in FIG. 7 . The final implant also matches and maintains theproper spinal lordosis. The endplate surfaces match the bone surfacesand extend to the perimeter of the vertebral bodies for optimalhomogenous load carrying and distribution, support, and marriage to thebone, which will make subsidence of the implant impossible and fasterrecovery of the patient. The angle of the implants can be infinitelyadjusted in the design, to match the proper bone angles and thus spinallordosis for optimal sagittal balance. An additional benefit of coveringas much as possible of the bone's endplates is to prevent heterotopicossification (HO).

Together with the matching of the implant endplates' shape to the shapeof the bone endplates, the special bone penetrating friction details onthe implant's endplate surfaces provide additional grip and adhesion tothe bone, and a faster strong bond to the bone. One benefit of 3 dprinting the endplate material is that open or lattice structures caneasily be added where desired, to control the bone in-growth to themarrying vertebral surfaces, as shown in FIG. 8 . Another benefit of 3Dprinting the endplate material is that the printed surface is relativelyrough, which is excellent for bone adhesion.

Patients have varying angles between the vertebrae bone endplates, whichdetermines the lordosis and kyphosis in their spines. These angles arespecific to each patient and must be respected to maintain optimalsagittal balance and healthy movement and spacing in the facets andbetween the vertebrae, as shown in FIG. 9 .

Current known artificial disk designs are known to fail when thelordosis of the spine is not respected and restored during surgery. Thishappens—for instance—in cases of hyperlordosis, when there is noavailability of fusion cages with a high enough angle to correctlyrecreate the natural lordosis. The approach of the presently disclosedinvention addresses such problems directly and without limits to angle,size, spacing or shape. With this new technology, any natural anglebetween a pair of vertebrae can be matched, as well as any height, asillustrated in FIG. 10 , to maintain the right lordosis, plus fix andpotentially correct eventual scoliosis. Especially scoliosis caused by alateral tilted pelvis (caused by difference of leg lengths i.e.) can becorrected so that the L5 vertebra can be aligned horizontally byadjusting the angle of the misaligned Si (Top level of the Sacrum), tolet nature and physiotherapy self-correct the spine above L5 and thusthe scoliosis.

The implant of the present disclosure is designed in such a way, thatwhen the spine is in the neutral position (in sagittal balance), thecore (304) of the artificial disk is oriented parallel, as shown inFIGS. 10A-10B, and the angle and morphology of the implant's endplates(300) precisely matches the patient's anatomy. This facilitates equalfreedom of movement in all directions from the neutral position of theartificial disk. In some instances, the core can be comprised of onebiocompatible visco-elastic material, and in some instances, two or morevisco-elastic materials having different stiffnesses, as shown in FIG.11A.

It must be noted that currently known artificial disk implants cannotaccommodate the endless variations and often cause metal-to-metalcontact points or instability due to their mechanical components gettingaffected or shifting out of position, as illustrated in FIG. 12 .

According to the embodiments of the present invention, the firmer, loadbearing section of the core is located closer to the spinal cord, ratherthan in the center of natural intervertebral disk (like most otherimplants), to facilitate good angular movement, while minimizing thedynamics in the facet joints. In other instances, the core can bemanually shifted to any desired location.

According to some embodiments of the present disclosure, the core has afloating Center Of Rotation (COR). The softer core material is locatedin the remaining space between the tougher core and the perimeter, whichenables easier compression during flexion, extension and lateralbending, so the vertical displacement of the facet joints and thestretching of the Posterior Longitudinal Ligament (PLL) are minimized.The goal of this is to minimize the wear of the facet joints and thestress on them, as shown in FIG. 11B which is a seesaw-like illustrationof much vertical displacement of the facet joints in a normal disk,versus minimal vertical displacement of the facets in the case of havingthe tougher core closer to the spinal cord, in accordance with anembodiment of the present disclosure. Under extension (bendingbackwards) and flexion (bending forwards), the COR resides inside theflexible core, moving slightly in AP direction. Under lateral bending(sideways), the COR resides inside the flexible core, moving slightlyfrom left to right. Under axial rotation, the COR resides outside theflexible core in the lumbar area, closer to the backside of the spinalcord, as dictated by the shape of the lumbar facet joints, so the coreallows lateral shearing to facilitate this. All these movements imitatethe behavior of the natural disk.

Under compression the stiffer section of the core maintains proper diskheight and prevents damage to the facet joints and maintains properneural pathways in the spine. Using proper preoperative medical imagingtechniques combined with our 3D printing approach, the surgeon has theability to infinitely adjust the endplate thickness, size, angle andshape. The goal is to minimize over-distraction (which causes excessivepain) and recovery time. With competitive designs, the surgeon is oftenforced to place an oversized implant, which adds significant stretchingto the tendons and ligaments (beyond their normal maximum range, asshown in FIG. 13 ), and can cause improper alignments and angles, butalso may cause additional compression of adjacent intervertebral disks,causing a poor solution for the patient. With the system of the presentinvention the surgeon is able to determine the correct height and anglesfor the patient prior to surgery.

The core can be shifted more anterior or posterior (relative to theendplate surfaces) as desired, prior to 3D printing. The stiffness ofthe core components can be adjusted in function of the patient's sizeand weight. When desired, one or more lips, each with one or morescrew-holes in them, can be added anywhere on the perimeter of theendplates to mechanically secure the implant with additional screws.This further prevents any possible migration of the implant. (FIG. 14A).In case of the hyperlordosis implants, it is possible to add screw holesin the endplates to prevent implant migration from too high angledifferences and resulting AP shearing forces. (FIG. 14B)

For cases of slipping disks, an extra tough core can be created,optionally with extra barriers placed inside the soft core of theimplant, to mechanically limit the displacement of the endplates, whichcan add extra stability to the realigned vertebrae. The use of medicalimaging to produce medical 3D printed implants also extends to thecreation of other support structures which could be bolted onto thefusion cages (or combine them with the fusion cage as one 3D printedpart), to offer much more strength and stability to a fusion of 2 ormore vertebrae, if needed, as an alternative to posterior stabilizationwith screws and rods that damage the soft tissues posterior to thespine.

This would be plates, which are an offset of the bone surfaces (afterrealigned into the proper position in the 3D medical software), to forma plate of an infinitely adjustable desired thickness, filled with holesto first mount the plate onto the placed fusion cage, and secondly toadditionally screw the plate to the rest of the outer surface of thevertebrae (above and below the fusion cage). Such an interlocking platemay span over more than 2 vertebrae, if needed. The plate 500 followsthe curvature of the bone, thus has additional strength due to thenatural cylindrical curvature, as illustrated in FIG. 15 .

The spine will effectively be upgraded because of an implant like this,since it will have the same motion as the natural intervertebral disk,but it will be stronger and more durable and not subject to dehydrationby vertical static pressure (working while standing or sitting still alot). Where the central part of the vertebral superior and inferior boneendplates could normally collapse in certain high shock load/accidentsituations (falling on one's behind), the presence of this artificialdisk would prevent bone collapse, as the stiff titanium implantendplates would distribute that load more to the outer edges of thebone, which are the strongest part of the vertebral main bodies.

As illustrated in FIG. 16 , one can see the support structures of theligaments that specifically restrict rotation of the L4 and L5vertebrae, but allow flexion and extension. To allow rotation about thevertical axis, the vertebrae need to undergo lateral translation, whichin turn needs the intervertebral disk to allow lateral shearing. Theimplant of the present disclosure is designed to accommodate any ofthese movements.

Optional protrusion shapes 710 (any shape, like spikes, teeth, keels,lattice pyramids, and others) can be added to the outer surface of theimplant endplates 700 to add more grip on the mating bone surfaceagainst migration, as shown in FIG. 17 .

According to another embodiment of the present disclosure, the endplatesof the artificial disk implant can have a gripping structure for ease ofgripping the disk with various gripping tools. As illustrated in FIGS.18-20 , a top endplate 800 includes a first portion 810 a having asurface matching the morphology of the corresponding bone endplate and asecond portion 810 b having a plurality of gripping slots 950 protrudinginwardly for receiving a gripping tool. Likewise, a bottom endplate 900includes a first portion 910 a having a surface matching morphology of acorresponding bone endplate and a second portion 910 b with a pluralityof gripping slots 950 protruding inwardly for receiving a gripping tool.It will be appreciated by a person skilled in the art that a first andsecond portions of the top and bottom endplates can be formed using 3Dprinting methods as one integral part. In some instances, the top andbottom endplates can be formed by attaching a first portion and a secondportion as two separate parts using commercially available attachingmeans such as glue or adhesive, for example. The gripping tool can gripthe disk at different slot positions as illustrated in FIGS. 21A-21C,thereby allowing to access the disk with the gripping tool at differentangles, which makes it easier to place the artificial replacement diskbetween the bone endplates without damaging other organs such asarteries, for example. With a two-prong gripping tool the disk can begripped at slots 950 a and 950 c, or 950 a and 950 d, and so on.Likewise, with a four-prong tool, the disk can be clamped at 950 a/950 dand 950 c/950 d slots at various positions on the perimeter of a secondportion of an endplate. With a six-prong gripping tool, the endplate canbe clamped at three slots from each side of a second portion of anendplate, as illustrated on FIGS. 22A-22C.

Now referring to FIG. 23 , one exemplary method 2300 of fabricating anartificial replacement disk comprises the steps of acquiringthree-dimensional image scan data of spine or neck using at least one ofcomputerized tomography (CT) scan and magnetic resonance imaging (MRI)2302, converting the CT and/or MRI scan to an engineering file 2304,creating a three-dimensional digital model of a target disk space inbetween a superior vertebrae and an inferior vertebrae 2306, printing afirst endplate and a second endplate 2308, and injection molding a corein between the first inner surface and the second inner surface tocreate the artificial replacement disk assembly 2310.

FIGS. 24A-24F depict a cross-sectional view of the steps of the methodof FIG. 23 . In FIG. 24A, a spine portion is scanned using CT or MRItechnologies. The spine portion includes a superior vertebrae 2402 andan inferior vertebrae 2404. The scan data is converted into anengineering file to create a three-dimensional digital model 2406 of atarget disk space in between a superior vertebrae and an inferiorvertebrae as shown in FIGS. 24B-24C. The digital model 2406 may becreated by filling in an area in between the vertebral endplates of thesuperior and inferior vertebrae, where the top surface of the digitalmodel matches the surface morphology of the superior vertebrae and thebottom surface of the digital model matches the surface morphology ofthe inferior vertebrae.

Based on the digital model 2406, two endplates may be printed using 3-Dprinting technologies. FIG. 24D shows a printed first endplate 2408 andsecond endplate 2410. The first endplate 2408 has an outer surface 2412that matches a surface morphology of the superior vertebrae 2402 whilethe second endplate 2410 has an outer surface 2414 that matches asurface morphology of the inferior vertebrae 2404. The first endplate2408 has a textured inner surface 2416 and the second endplate 2410 hasa textured inner surface 2416 too. The texture may be any rough textureincluding, but not limited to, bumps (such as on the inner surface ofthe endplate of FIG. 18 ), a lattice structure (such as on the innersurface of the endplate of FIG. 15 ), a porous structure with many smallnooks and crannies (similar to the friction details of FIG. 8 ), and thelike. Texturing the first inner surface 2416 and the second innersurface 2418 increases the surface area of the inner surfaces, andgreatly improves bonding with the core 2424 as will be discussedshortly.

The first inner surface 2410 and the second inner surface 2416 may beparallel to each other in order for the core 2424 to have a uniformthickness. The two endplates may be printed such that there issufficient space 2417 for a core 2424 in between the first inner surface2410 and the second inner surface 2416. The space 2417 for the core canbe made thinner or thicker depending on preferred core 2424 thickness.The space 2817 for the core is preferably centered in between the firstouter surface 2412 and the second outer surface 2414, but may be locatedat any point in between the endplates.

The first endplate 2408 and the second endplate 2410 are made of anybiocompatible material, preferably a ceramic or a non-oxidizing metal.Such materials are hard and can withstand high heat without breaking ordeforming, making them ideal injection molding core 2424 in between theendplates. The endplates may have gripping slots as previouslydescribed.

The core 2422 may be injection molded in between the endplates. In FIG.24E, the first endplate 2408 is the top of the mold, the second endplate2410 is the bottom of the mold. A cylindrical portion 2420 surrounds thecore formation area 2422, creating an airtight seal around the coreformation area 2422, apart from the injection valve.

Once the mold is ready, an elastomeric core 2424 is injection molded inbetween the endplates. The textured inner surfaces of the endplatesreadily absorb the core 2424 while it's still liquid during the start ofthe molding process. When the core 2424 cools and solidifies, it becomespermanently fused with the endplates. The first endplate 2408, core2424, and the second endplate 2410 are firmly held together and form theartificial replacement disk assembly 2426.

FIG. 24F shows the assembly 2426 implanted in between the superiorvertebrae 2402 and the inferior vertebrae.

Now referring to FIG. 25 , one exemplary method 2500 of fabricating anartificial replacement disk comprises the steps of acquiringthree-dimensional image scan data of spine or neck using at least one ofcomputerized tomography (CT) scan and magnetic resonance imaging (MRI)2502, converting the CT and/or MRI scan to an engineering file 2504,creating a three-dimensional digital model of a target disk space inbetween a superior vertebrae and an inferior vertebrae 2506, printing afirst endplate and a second endplate 2508, molding a core 2510, fusingthe core 2510 to the endplates to create the artificial replacement diskassembly 2512. This method 2500 is similar to the method of FIG. 23 ,but the core 2424 of the artificial replacement disk is not molded inbetween the endplates and the endplates do not require textured innersurfaces. Rather this core 2424 is molded inside of a mold that emulatesthe core formation area 2422, wherein the core 2424 still ends upmatching the surface morphology of the inner surfaces of the endplates.Furthermore, this method 2500 involves the step of fusing the core tothe endplates. Fusion may be achieved by using a glue or adhesive thebond the core in between the endplates. Alternatively, the core may beplaced in between the inner surfaces of the endplates to form to form asubassembly. The subassembly is then subjected to ultrasonic vibrationsto induce ultrasonic bonding at the inner surfaces of the endplates,fusing the core and the endplates together.

While at least one exemplary embodiment has been presented in theforegoing detailed description of the invention, it should beappreciated that a vast number of variations exist. It should also beappreciated that the exemplary embodiment or exemplary embodiments areonly examples, and are not intended to limit the scope, applicability,or configuration of the invention in any way. Rather, the foregoingdetailed description will provide those skilled in the art with aconvenient road map for implementing an exemplary embodiment of theinvention, it being understood that various changes may be made in thefunction and arrangement of elements described in an exemplaryembodiment without departing from the scope of the invention as setforth in the appended claims and their legal equivalents.

Although the invention is described herein with reference to specificembodiments, various modifications and changes can be made withoutdeparting from the scope of the present invention as set forth in theclaims below. Accordingly, the specification and figures are to beregarded in an illustrative rather than a restrictive sense, and allsuch modifications are intended to be included within the scope of thepresent invention. Any benefits, advantages, or solutions to problemsthat are described herein with regard to specific embodiments are notintended to be construed as a critical, required, or essential featureor element of any or all the claims.

Unless stated otherwise, terms such as “first” and “second” are used toarbitrarily distinguish between the elements such terms describe. Thus,these terms are not necessarily intended to indicate temporal or otherprioritization of such elements.

The foregoing detailed description is merely exemplary in nature and isnot intended to limit the invention or application and uses of theinvention. Furthermore, there is no intention to be bound by anyexpressed or implied theory presented in the preceding technical field,background, brief summary, or the following detailed description.

We claim:
 1. An artificial replacement disk, wherein an upper surface ofthe disk is configured to contact a superior vertebrae; the uppersurface of the disk matches a first surface morphology of the superiorvertebrae; a lower surface of the disk is configured to contact aninferior vertebrae; the lower surface of the disk matches a secondsurface morphology of the inferior vertebrae; and the disk comprises aplurality of slots, the plurality of slots including at least a firstset of slots to receive a gripping tool in a first position and a secondset of slots to receive the gripping tool in a second position.
 2. Theartificial replacement disk of claim 1, wherein a three-dimensionalmodel of a target disk space is modified to produce at least one ofproper angle and spacing in between the superior vertebrae and theinferior vertebrae.
 3. The artificial replacement disk of claim 1,wherein a material composition of the disk includes a ceramic.
 4. Theartificial replacement disk of claim 1, wherein a material compositionof the disk is substantially aluminum oxide.
 5. The artificialreplacement disk of claim 1, wherein a material composition of the diskincludes a non-corrosive metal.
 6. The artificial replacement disk ofclaim 1, wherein at least one of the upper surface and the lower surfaceof the disk is textured to promote bone in-growth.
 7. A method forfabricating an artificial replacement disk comprising: acquiringthree-dimensional image scan data of spine or neck using at least one ofcomputerized tomography (CT) scan and magnetic resonance imaging (MRI);converting the CT and/or MRI scan to an engineering file; creating athree-dimensional digital model of a target disk space in between asuperior vertebrae and an inferior vertebrae; fabricating the artificialreplacement disk, wherein an upper surface of the disk is configured tocontact a superior vertebrae; the upper surface of the disk matches afirst surface morphology of the superior vertebrae; a lower surface ofthe disk is configured to contact an inferior vertebrae; the lowersurface of the disk matches a second surface morphology of the inferiorvertebrae; and the disk comprises a plurality of slots, the plurality ofslots including at least a first set of slots to receive a gripping toolin a first position and a second set of slots to receive the grippingtool in a second position.
 8. The method of claim 7, wherein thethree-dimensional model of the target disk space is modified to produceat least one of proper angle and spacing in between the superiorvertebrae and the inferior vertebrae.
 9. The method of claim 7, whereina material composition of the disk includes a ceramic.
 10. The method ofclaim 7, wherein a material composition of the disk is substantiallyaluminum oxide.
 11. The method of claim 7, wherein a materialcomposition of the disk includes a non-corrosive metal.
 12. The methodof claim 7, wherein at least one of the upper surface and the lowersurface of the disk is textured to promote bone in-growth.
 13. Themethod of claim 7, wherein the disk is fabricated via injection molding.14. The method of claim 7, wherein the disk is fabricated via 3Dprinting.